Senators grill FDA commissioner on outbreak

Food and Drug Administration Commissioner Margaret Hamburg acknowledged Thursday that the FDA could have acted more decisively against the company implicated in the meningitis outbreak but asked lawmakers to clarify and strengthen the agency’s powers to regulate compounding pharmacies.

Given more than a decade of documented safety and other violations at the New England Compounding Center, “I wish that [FDA’s] responses had been more timely … that they had been better coordinated with the states,” Hamburg said at a hearing of the Senate Health, Education, Labor and Pensions Committee.

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But Hamburg repeated the message she told a more skeptical House hearing Wednesday: The FDA’s authority over the compounding pharmacies like NECC is “limited, unclear and contested.” That impedes FDA’s ability to act, she said, and the agency’s regulatory powers need to be clarified and re-enforced. Some of these compounding pharmacies have gone beyond their traditional role in making small batches of drugs for specific patients and act more like small drug manufacturers — without the regulation that drug makers undergo.

Senators expressed bipartisan interest in plugging regulatory gaps, and there was general agreement from stakeholders who testified. Kasey Thompson of the American Society of Health-System Pharmacists came out strongly in favor of broader FDA regulation. And the main trade group of the compounders, the International Academy of Compounding Pharmacists, agreed that Congress should pass legislation clarifying the FDA’s regulatory role, IACP Executive Vice President David Miller testified. The group had opposed earlier efforts to strengthen the FDA role.

HELP Committee Chairman Tom Harkin (D-Iowa) said, “We will forge ahead in developing legislation. Hopefully we will have something soon next year that we can move ahead on, so we can put this sad chapter behind us.” Some Democrats in the House hearing want to press for legislation in the lame-duck session.

That was a contrast from the hearing Wednesday before the Energy and Commerce Oversight subcommittee at which several Republican lawmakers were skeptical that the FDA needed more authority. They suggested the problem was the agency’s failure to use its existing powers to prevent the crisis at NECC. So far, the NECC-produced tainted steroid injections have been linked to the deaths of 32 people and more than 460 illnesses in 19 states.

The co-owner of NECC, who took the Fifth Amendment and declined to testify before the House panel, did not appear before the Senate panel. Harkin said, “There’s no reason to go through that charade here, with him.”

Hamburg said this morning that the agency is inviting representatives from all 50 states to a Dec. 19 meeting on how federal and state regulators can coordinate the regulation of compounding pharmacies. And Harkin said he and ranking member Mike Enzi of Wyoming would send letters to the Boards of Pharmacy in all 50 states to request information about sterile compounding pharmacies in their jurisdictions.

The day of “Self-Regulating” and “Self-Policing” on the Assumption that Ethical Behavior will be adhered to and maintained by an individual or Company, is long gone! Gone, because it has long been replaced by GREED! When it comes to a choice between Ethical Behavior and “Profits”, “Profits” will win every time This is why Regulations and STRICT ENFORCEMENT of those Regulations through regular inspections are, not only essential, but Imperative! Any one or any Agency that “Assumes “ otherwise, or “Assumes” anything, is either too lazy or too incompetent to verify! It occurs to me that the FDA falls into the latter category!